Magazine article Clinical Psychiatry News

Paroxetine Is First SSRI to Target All PTSD Symptoms: Reduced Reexperiencing and Hyperarousal. (Newly Approved Indication)

Magazine article Clinical Psychiatry News

Paroxetine Is First SSRI to Target All PTSD Symptoms: Reduced Reexperiencing and Hyperarousal. (Newly Approved Indication)

Article excerpt

For the first time, a selective serotonin reuptake inhibitor has demonstrated a therapeutic effect in men and women on all three symptom clusters of posttraumatic stress disorder.

According to the authors of a 12-week multicenter placebo-controlled study of 551 outpatients meeting DSM-IV criteria for chronic posttraumatic stress disorder (PTSD), those treated with paroxetine had significantly greater improvements in the severity and changes in symptoms of PTSD, compared with those on placebo. Symptom effects were evaluated using the Clinician-Administered PTSD scale, part 2.

Significantly more patients treated with paroxetine had a Clinical Global Impressions improvement rating of "very much" or "much improved" by the end of the study, compared with those treated with placebo, the investigators noted. This response was seen in 62% of the 183 who received 20 mg of paroxetine a day and 54% of the 182 who received 40 mg a day, compared with 37% of the 186 patients who received placebo.

Paroxetine also had a significant impact on reducing reexperiencing, avoidance and /or numbing, and hyperarousal, making this the first study known "to demonstrate that an SSRI effectively ameliorates each of the major symptom clusters of PTSD," they said (Am J. Psychiatry 158[12]:1982-88, 2001).

The study, published last month, was supported by GlaxoSmithKline, which manufactures paroxetine under the trade name Paxil, and by a National Institute of Mental Health grant to the lead investigator, Dr. Randall Marshall, who has served as a consultant to GlaxoSmithKline.

Shortly after the publication of this study, the Food and Drug Administration approved paroxetine for treating PTSD. The company had filed an application for approval in July 2000.

The only other drug approved to treat PTSD is sertraline (Zoloft), which has been shown to have a significant impact over placebo in reducing avoidance and/or numbing symptoms, and hyper-arousal but not reexperiencing, according to the study (Approval of sertraline for PTSD in 1999 was based on two positive studies of mostly civilian women; a study of veterans and another civilian study were negative.) Fluoxetine (Prozac) has been associated with significant improvements in hyperarousal and numbing symptoms, but not in intrusive or avoidance symptoms.

In an interview, Dr. Marshall, who is director of trauma studies at New York State Psychiatric Institute, New York, offered several possible explanations for why his study is the first to show such an impact.

"We had enough power to actually show improvement in all three symptom clusters. ...I also think paroxetine is a particularly good medication for PTSD because it has such a calming effect, and it does not create insomnia."

"The main issue is not that one drug is better than the other, but that we answered several important unanswered scientific questions with PTSD," namely, that a treatment can have an impact on all three clusters and can be effective in both men and women.

This also could be true for the other SSRIs, he noted.

Dr. Marshall said that another important difference between this study and previous studies was that patients with treatment-refractory PTSD, who have received multiple treatments and are more likely to be on disability, were screened out before enrollment. …

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